Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE)
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|ClinicalTrials.gov Identifier: NCT02323451|
Recruitment Status : Unknown
Verified December 2014 by Shanghai Qisheng Biological Preparation Co., Ltd..
Recruitment status was: Recruiting
First Posted : December 23, 2014
Last Update Posted : December 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Medical Chitosan Drug: Sodium Hyaluronate Injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicentre, Randomized, Double-blinded, Parallel-controlled, Non-inferiority Clinical Study Of Safety and Efficacy Of Medical Chitosan for Knee Osteoarthritis Compared With Sodium Hyaluronate Injection|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: Medical Chitosan
Medical Chitosan, 2ml/vial (12mg/ml), intra-articular injection with a volume less than 2ml every two weeks, a total of 3 times
Device: Medical Chitosan
Active Comparator: Sodium Hyaluronate Injection
Sodium Hyaluronate Injection, 2ml/vial (10mg/ml), intra-articular injection with a volume less than 2ml every one weeks, a total of 5 times.
Drug: Sodium Hyaluronate Injection
- Visual Analogue Scale for knee pain [ Time Frame: six weeks of the initial injection ]The investigator and the subject both evaluate the pain intensity per VAS before injection. VAS ranges from o to 10, 0=no pain, 10=pain as bad as can be.
- WOMAC for knee pain [ Time Frame: six weeks of the initial injection ]WOMAC includes 3 items: pain, stiff and physiological function. 0=no, 4=as bad as can be.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323451
|Contact: Changqing Zhang, PhDemail@example.com|
|Contact: Shengbao Chen, MDfirstname.lastname@example.org|
|Principal Investigator:||Changqing Zhang, PhD||Shanghai,China.Shanghai Sixth People's Hospital. Orthopedics. Recruiting. No. 600. Yishan Rd. Shanghai. Post Code:200233.|
|Principal Investigator:||Shigui Yan, PhD||Hangzhou,Chian. The Second Affiliated Hospital of Zhejiang University School of Medicine. Orthopedics. Not yet recruiting. No.88 Jiefang Road Hangzhou.China Post Code：310009|